Diabetic Foot Ulcers
Conditions
Keywords
diabetic, diabetes mellitus, foot, ulcers, Floxin, oral antibiotic, topical cream
Brief summary
224 adults with diabetic foot ulcers will be randomized to either magainin peptide (MSI-78) or ofloxacin (FLOXIN, Ortho-McNeil Pharmaceutical Corporation) an oral fluoroquinolone antibiotic.
Detailed description
Approximately 224 adults will be enrolled in an outpatient Phase III study to compare the safety and efficacy of topically applied magainin peptide (MSI-78) to that of ofloxacin (FLOXIN, Ortho-McNeil Pharmaceutical Corporation) an oral fluoroquinolone antibiotic, in the treatment of infected diabetic foot ulcers. This is a randomized, controlled, double-blind trial that will involve twenty or more clinical centers.
Interventions
Sponsors
Genaera Corporation
Abeona Therapeutics, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Non-hospitalized ambulatory patients with diabetes mellitus * Men or Women greater than 18 years old * Patients must be considered reliable, willing and able to give consent * Female patients must be postmenopausal for a least 6 months or surgically sterilized * Localized infection of the ulcer that would ordinarily be treated on an outpatient basis * Patients who have been previously treated or are currently under treatment for a localized infections of an ulcer may be enrolled in there has been an adequate response to treatment and ulcer is still infected * Patient must have radiograph within two weeks of entry showing no evidence of cortical destruction consistent with osteomyelitis * Patient must have a palpable dorsalis pedis or posterior tibial pulse in the affected foot * Patient may not be taking or have received any other investigational therapy or approved therapy within 30 days prior to entry
Exclusion criteria
* Patients requiring concurrent local or systemic antimicrobials during the study period for other infections * Patients who are currently treated or awaiting dialysis * Patients who are unable to care for their ulcers * Patients with known alcohol or substance abuse within 6 months or study entry * Patients with significant GI problems or surgery that might interfere with the absorption of ofloxacin * Patients who are currently receiving systemic corticosteroids, immunosuppressives, antivirals, radiation therapy or cytotoxic agents * Patients who currently require treatment or a primary or metastatic malignancy or have systemically immunocompromising disease. * Previous enrollment in this study or previous treatment with MSI-78 Topical Cream * Patients with gangrene or severely impaired arterial supply to any portion of the affected foot * Other conditions considered by the investigator to be sound reason for disqualification * Patients with any known allergy to ofloxacin, other quinolone antibiotics, magainin peptides or ingredients of the vehicle cream * Women who are breast feeding, pregnant or attempting to become pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in clinical signs and symptoms of the infection | Study day 10 | a comparison of the reduction in clinical signs and symptoms of infection between MSI-78 topical therapy and conventional oral antibiotic therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| microbiological response to therapy, | Study day 10 | Measure microbiological response to therapy |
| Wound infection score | Study day 10 | Measure wound infection score. |
| Total wound score | Study day 10 | Measure total wound score. |
| Wound Area | Study day 10 | Measure wound area. |
| Wound Depth | Study day 10 | Measure wound depth. |
Countries
United States
Outcome results
None listed